CancerNCT07583069
Psychosocial Effects of a Trauma-Informed Artificial Intelligence-Supported Chatbot in Adults Newly Diagnosed With Cancer
A study testing Trauma-Informed AI-Supported Chatbot in people with Cancer and Psychosocial Distress, run by Koç University.
Trial summary
The goal of this clinical trial is to evaluate whether a trauma-informed, artificial intelligence-supported chatbot can reduce psychological distress and unmet psychosocial needs in adults newly diagnosed with cancer.: Does the chatbot reduce trauma-related distress and anxiety levels compared to standard care? Does… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Psychosocial Distress, Trauma and Stress Related Disorders
- What is being tested?
- Trauma-Informed AI-Supported Chatbot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age,
- Able to speak and understand Turkish,
- Without any cognitive, visual, or auditory impairments,
- Diagnosed with cancer within the last month (Stage I, II, and III) (regardless of cancer type),
- Have started active cancer treatment,
- Have access to a digital device and the internet,
- Volunteer to participate in the study will be included.
Who cannot join
- Patients participating in another simultaneous psychosocial/digital intervention study,
- Patients diagnosed with advanced stage (Stage IV) cancer, in the terminal phase and with metastases,
- Patients diagnosed with schizophrenia, bipolar disorder, substance abuse, depression and anxiety disorders will be excluded.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Psychosocial Effects of a Trauma-Informed Care-Based Artificial Intelligence-Supported Chatbot in Newly Diagnosed Cancer Patients: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate whether a trauma-informed, artificial intelligence-supported chatbot can reduce psychological distress and unmet psychosocial needs in adults newly diagnosed with cancer.:
- Does the chatbot reduce trauma-related distress and anxiety levels compared to standard care?
- Does the chatbot decrease unmet psychosocial needs in patients following a new cancer diagnosis? Researchers will compare the chatbot intervention to standard care to determine whether the chatbot provides additional psychosocial benefit.
Read more
Participants will:
- Be randomly assigned to either the chatbot intervention group or the standard care group
- Use the chatbot freely for 12 weeks (intervention group only)
- Complete questionnaires at baseline, 1 month, and 3 months
- Be monitored for any psychological risk indicators during the study period
Read the detailed description
Receiving a cancer diagnosis is a potentially traumatic experience associated with significant psychological distress, anxiety, and unmet psychosocial needs. Despite the recognized importance of psychosocial care in oncology, barriers such as limited healthcare resources, heavy workload, and insufficient access to timely support may prevent patients from receiving adequate psychosocial interventions during the early stages following diagnosis.
Trauma-Informed Care (TIC) is an approach that recognizes the psychological impact of traumatic experiences and aims to provide support through principles including safety, trustworthiness, empowerment, collaboration, and cultural sensitivity. Integrating TIC principles into digital health interventions may provide accessible and individualized psychosocial support for patients newly diagnosed with cancer.
This study aims to evaluate the effectiveness of a trauma-informed, artificial intelligence-supported chatbot developed to provide early psychosocial support to adults newly diagnosed with cancer. The chatbot is designed to deliver empathetic and supportive interactions grounded in trauma-informed care principles. It provides psycho-education, emotional support, coping facilitation, and guidance toward professional support resources when needed, without offering medical diagnosis or treatment recommendations.
The study is designed as a randomized controlled trial consisting of an intervention group receiving access to the chatbot in addition to standard care and a control group receiving standard care alone. Outcomes related to trauma-related distress, anxiety and psychosocial needs will be evaluated over a 12-week period.
The chatbot system incorporates predefined safety mechanisms and interaction-based monitoring to identify potential psychological risk indicators during use. Participants identified as potentially at risk may be directed toward appropriate professional support resources according to the study safety protocol.
- Being tested
- Trauma-Informed AI-Supported Chatbot
- Keywords
- cancer diagnosis, unmet psychosocial needs, trauma-informed care, AI-powered chatbot
- Medical subject headings
- Neoplasms, Trauma and Stressor Related Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-Informed AI-Supported ChatbotOther
The intervention consists of a trauma-informed, AI-supported chatbot designed to provide psychosocial support to adults newly diagnosed with cancer. The chatbot is grounded in trauma-informed care principles, including safety, trustworthiness, empowerment, collaboration, and sensitivity to emotional distress following diagnosis. It enables free-text, user-initiated conversations and delivers empathetic, non-directive support aimed at facilitating emotional expression, coping, and adaptation to diagnosis. The chatbot does not provide medical, pharmacological, nutritional, or exercise advice. Instead, it focuses on psychosocial support and encourages users to seek professional help when appropriate. The system incorporates predefined safety rules and continuous interaction-based risk monitoring; when indicators of psychological risk are detected, users are guided toward appropriate support resources. Participants are granted access to the chatbot for a 12-week period.
| Study group | Role | What they receive |
|---|---|---|
| Chatbot | Experimental | Participants in this arm will receive access to a trauma-informed, artificial intelligence-supported chatbot designed to provide psychosocial support following a new cancer diagnosis. The chatbot allows free-text interaction and is available for use over a 12-week period. It is designed in line with trauma-informed care principles and provides emotional support, coping facilitation, and guidance toward professional help when needed. Participants will also receive standard care. Chatbot interactions will be monitored for potential psychological risk indicators, and appropriate guidance will be provided if risk is detected. Receives: Other: Trauma-Informed AI-Supported Chatbot |
| Control | No intervention | Participants in this arm will receive standard care as routinely provided by the institution. No chatbot intervention will be provided during the study period. Participants may access usual psychosocial or clinical support services as needed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trauma-related distress
Trauma-related distress associated with cancer diagnosis will be assessed using the Impact of Event Scale-Revised (IES-R). The IES-R is a validated self-report instrument measuring intrusion, avoidance, and hyperarousal symptoms. Total scores range from 0 to 88, with higher scores indicating greater trauma-related distress.
Measured: Baseline, 1 and 3 months
Secondary outcomes (2)
Anxiety levels
Anxiety will be measured using the State-Trait Anxiety Inventory (STAI), which assesses both state and trait anxiety levels. Scores for each sub-scale range from 20 to 80, with higher scores indicating higher anxiety levels.
Measured: Baseline, 1 and 3 months
Unmet psychosocial needs
Psychosocial needs will be assessed using the Psychosocial Needs Inventory (PNI), a 48-item scale evaluating the importance and fulfillment of psychosocial needs across multiple domains. Items are scored on a 1-5 Likert scale. Higher scores indicate greater perceived importance and/or better fulfillment of psychosocial needs.
Measured: Baseline, 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor
- Investigators
- Nevra Didem Kılınç, PhD(c), Principal investigator, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583069
- Sponsor's protocol ID
- 2025.468.IRB3.232
- Other IDs
- 325S436
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to the sensitive nature of psychosocial data collected from patients newly diagnosed with cancer and to ensure participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Psychosocial Effects of a Trauma-Informed Care-Based Artificial Intelligence-Supported Chatbot in Newly Diagnosed Cancer Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07583069
- Acronym / sponsor ID
- 2025.468.IRB3.232
- Keywords
- cancer diagnosis, unmet psychosocial needs, trauma-informed care, AI-powered chatbot
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate whether a trauma-informed, artificial intelligence-supported chatbot can reduce psychological distress and unmet psychosocial needs in adults newly diagnosed with cancer.:
- Does the chatbot reduce trauma-related distress and anxiety levels compared to standard care?
- Does the chatbot decrease unmet psychosocial needs in patients following a new cancer diagnosis? Researchers will compare the chatbot intervention to standard care to determine whether the chatbot provides additional psychosocial benefit.
Participants will:
- Be randomly assigned to either the chatbot intervention group or the standard care group
- Use the chatbot freely for 12 weeks (intervention group only)
- Complete questionnaires at baseline, 1 month, and 3 months
- Be monitored for any psychological risk indicators during the study period
Detailed description
Receiving a cancer diagnosis is a potentially traumatic experience associated with significant psychological distress, anxiety, and unmet psychosocial needs. Despite the recognized importance of psychosocial care in oncology, barriers such as limited healthcare resources, heavy workload, and insufficient access to timely support may prevent patients from receiving adequate psychosocial interventions during the early stages following diagnosis.
Trauma-Informed Care (TIC) is an approach that recognizes the psychological impact of traumatic experiences and aims to provide support through principles including safety, trustworthiness, empowerment, collaboration, and cultural sensitivity. Integrating TIC principles into digital health interventions may provide accessible and individualized psychosocial support for patients newly diagnosed with cancer.
This study aims to evaluate the effectiveness of a trauma-informed, artificial intelligence-supported chatbot developed to provide early psychosocial support to adults newly diagnosed with cancer. The chatbot is designed to deliver empathetic and supportive interactions grounded in trauma-informed care principles. It provides psycho-education, emotional support, coping facilitation, and guidance toward professional support resources when needed, without offering medical diagnosis or treatment recommendations.
The study is designed as a randomized controlled trial consisting of an intervention group receiving access to the chatbot in addition to standard care and a control group receiving standard care alone. Outcomes related to trauma-related distress, anxiety and psychosocial needs will be evaluated over a 12-week period.
The chatbot system incorporates predefined safety mechanisms and interaction-based monitoring to identify potential psychological risk indicators during use. Participants identified as potentially at risk may be directed toward appropriate professional support resources according to the study safety protocol.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chatbot | Experimental | Other: Trauma-Informed AI-Supported ChatbotParticipants in this arm will receive access to a trauma-informed, artificial intelligence-supported chatbot designed to provide psychosocial support following a new cancer diagnosis. The chatbot allows free-text interaction and is available for use over a 12-week period. It is designed in line with trauma-informed care principles and provides emotional support, coping facilitation, and guidance toward professional help when needed. Participants will also receive standard care. Chatbot interactions will be monitored for potential psychological risk indicators, and appropriate guidance will be provided if risk is detected. |
| Control | No intervention | –Participants in this arm will receive standard care as routinely provided by the institution. No chatbot intervention will be provided during the study period. Participants may access usual psychosocial or clinical support services as needed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Over 18 years of age,
- Able to speak and understand Turkish,
- Without any cognitive, visual, or auditory impairments,
- Diagnosed with cancer within the last month (Stage I, II, and III) (regardless of cancer type),
- Have started active cancer treatment,
Key exclusion criteria (3 listed)
- Patients participating in another simultaneous psychosocial/digital intervention study,
- Patients diagnosed with advanced stage (Stage IV) cancer, in the terminal phase and with metastases,
- Patients diagnosed with schizophrenia, bipolar disorder, substance abuse, depression and anxiety disorders will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trauma-Informed AI-Supported ChatbotThe intervention consists of a trauma-informed, AI-supported chatbot designed to provide psychosocial support to adults newly diagnosed with cancer. The chatbot is grounded in trauma-informed care principles, including safety, trustworthiness, empowerment, collaboration, and sensitivity to emotional distress following diagnosis. It enables free-text, user-initiated conversations and delivers empathetic, non-directive support aimed at facilitating emotional expression, coping, and adaptation to diagnosis. The chatbot does not provide medical, pharmacological, nutritional, or exercise advice. Instead, it focuses on psychosocial support and encourages users to seek professional help when appropriate. The system incorporates predefined safety rules and continuous interaction-based risk monitoring; when indicators of psychological risk are detected, users are guided toward appropriate support resources. Participants are granted access to the chatbot for a 12-week period. | Other | Chatbot |
Primary outcome
Trauma-related distress
Time frame: Baseline, 1 and 3 months
Trauma-related distress associated with cancer diagnosis will be assessed using the Impact of Event Scale-Revised (IES-R). The IES-R is a validated self-report instrument measuring intrusion, avoidance, and hyperarousal symptoms. Total scores range from 0 to 88, with higher scores indicating greater trauma-related distress.
2 secondary outcomes
Anxiety levels
Time frame: Baseline, 1 and 3 months
Unmet psychosocial needs
Time frame: Baseline, 1 and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available due to the sensitive nature of psychosocial data collected from patients newly diagnosed with cancer and to ensure participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nevra Didem Kılınç, PhD(c) principal investigator
Koç University
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-Informed AI-Supported Chatbot in people with Cancer and Psychosocial Distress, run by Koç University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nevra Didem Kılınç, PhD(c) (+9 0539 436 53 17, nozluk23@ku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trauma-related distress (time frame: Baseline, 1 and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.